MDSAP pilot program

Statement of Cooperation Among FDA – TGA – ANVISA – HPFB: MDSAP pilot

According to the SOC (Statement of Cooperation), the “Participants” composed of the The United States Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA), the Brazilian Health Surveillance Agency (ANVISA), and the Canadian Health Products and Food Branch (HPFB) aims to strengthen the existing mutual cooperation within the medical devices’ scientific and regulatory area by way of the MDSAP or Medical Device Single Audit Program.

MDSAP Goal:

Provide more effective, efficient and less burdensome regulatory oversight of the quality management systems of medical device manufacturers.

Allow a single audit satisfy the regulatory requirement of the participants.

MDSAP Objectives:

Operate a single audit program that provides confidence in program outcomes;

Promote more efficient and flexible use of regulatory resources through work-sharing and mutual acceptance among Participants, while respecting the sovereignty of each country;

Promote, over the longer term, greater global alignment of regulatory approaches and technical requirements based on international standards and best practices;

Promote consistency, predictability and transparency of regulatory programs by standardizing oversight practices and procedures of Participants over third-party auditing organizations, and the practices and procedures of participating third-party auditing organizations

The Participants (the US FDA, the Australian TGA, the Brazilian ANVISA, and the Canadian HPFB):

Intend to develop a joint work plan that’s appropriate for MDSAP. This plan will enable the pooling of technology, resources and services to improve the safety and oversight of medical devices in a more efficient manner that is also less burdensome for the entire industry.

Intend to fund its participation in activities under this SOC. All of the participants will maintain the confidentiality of the information shared under this program according to its own procedures and policies as permitted by its laws.

All participation is subject to the availability of appropriated funds- when applicable, personnel and other resources.

The SOC (Statement of Cooperation):

NOT intended to create binding obligations under international or domestic law. Nothing in this SOC is intended to negatively affect the Participants’ responsibilities or ability to carry out their regulatory responsibilities and programs in accordance with their respective laws and regulations.

May commence upon signature of all the Participants. A Participant may discontinue its participation in the development of the MDSAP upon sixty (60) calendar days’ written notice to the other Participants.

Feedback/Reviews:

It will stir up things in the QA/RA communities, but it’ll be advantageous to the industry to have the systems aligned globally. When implemented well, it will level the playing field for the companies, and it will allow the authorities to better focus their resources.

Although this is only a single audit, this will combine multiple QMS and even other regulations outside of QMS.

It’s been estimated that the cost will be 24%, 35% or 100% more than what is currently paid to get CMDCAS/CE certs.

Canada and Brazil are the ONLY two countries that are considering adopting this as a regulatory requirement. FDA and Europe have to keep it voluntary, for a wide range of reasons. Therefore, this will be skipped over by manufacturers abroad that sell into the USA, ironically the very same manufacturers the FDA wants assessed to their regulatory requirements.

Offering industry a voluntary system that is more expensive that what they are using makes no sense at all. This could actually further deter medical device manufacturers from taking an interest in Canada and Brazil, further shrinking their access to an already short supply of medical devices.

This has a greater potential damage to healthcare for those countries that make it mandatory.

Reduction of external audits is a huge incentive for a large corporation. Most of them, especially in the highly regulated sectors suffer from audit barrage and fatigue. They spend so many resources supporting external auditors that, if they could reduce the number of audits they have to endure it, it would be extremely attractive. But, then again, this program isn’t to help big companies. This is to gather information on smaller ones, especially those located overseas.

We recently participated in the qualification program of MDSAP. We might able to share more in the future.

If you are interested in the above Markets you can contact us for a preliminary discussion.